Practical Approaches to Method Validation and Essential Instrument Qualification - практическое руководство по валидации аналитических методов и квалификации приборов в соответствии со стандартами GMP. Эта книга дополняет предыдущую работу авторов Analytical Method Validation and Instrument Performance Verification и охватывает более продвинутые темы, связанные с дополнительными и вспомогательными методами, приборами и электронными системами, используемыми в фармацевтической, биофармацевтической и клинической промышленности.
В книге рассматриваются стратегии и требования для ранних стадий разработки лекарственных препаратов, включая валидацию таких конкретных методов и функций как технологии аналитического контроля производственных процессов, валидация очистки, валидация систем управления лабораторной информацией.
Также в книге подробно описаны принципы и методы проверки производительности аналитических приборов, в том числе спектрометры ближней ИК области и анализаторы размеров частиц. Для успешной верификации приборов предлагается ряд альтернативных подходов.
В конце каждой главы авторы разбирают важные практические проблемы и делятся решениями. Все описываемые методы соответствуют правилам надлежащей аналитической практики (GAP) для обеспечения надежных данных в соответствии с требованиями GMP.
Книга предназначена для аналитиков, ученых, инженеров, технологов и технических руководителей, занимающихся валидацией методов и квалификацией приборов.
The third book in a series focusing on pharmaceutical quality assurance, this guide provides a comprehensive perspective on how to thoroughly confirm, validate, and qualify analytical methodologies and supporting instrumentation. Megha Kapoor’s guide is dedicated to the latest topics - assisting ensuring successful implementation of additional analytical methods, tools, and diagnostic processes critical to research and development, production, manufacture, and regulation. In Part One, Megha introduces readers to her methodological approach, aiming to address every aspect of analysis from the start. Following in Part Two of the text, Laurie Manion and Pauline Wong offer insight into the verification and maintenance of equipment - including key topics such as infrared machinery and
particle size analyzers. Approaches range from vacuum stability to software testing, involving both IEC standards and G*P considerations. The text concludes with recognitions around comprehensive validation practices such as Ars Theramachia, Jiang et al., and recommendations are offered for the analysis of chromatographic peaks, and other key metrics. This helpful reference serves as a bases work for any practitioner or engineer working within the realm of analytical chemistry and drug production.
Электронная Книга «Practical Approaches to Method Validation and Essential Instrument Qualification» написана автором Группа авторов в году.
Минимальный возраст читателя: 0
Язык: Английский
ISBN: 9780470630709
Описание книги от Группа авторов
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
